ZUG, Switzerland, July 6, 2026
Pharvaris announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for deucrictibant immediate-release (IR) 20 mg capsules for the on-demand treatment of hereditary angioedema (HAE) attacks. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of April 23, 2027, marking a major regulatory milestone for the company’s lead oral therapy. If approved, deucrictibant IR would become the first oral bradykinin B2 receptor antagonist available for treating acute hereditary angioedema attacks, potentially offering patients a convenient alternative to injectable therapies currently used for rapid symptom management.
Phase 3 RAPIDe-3 Trial Demonstrated Strong Efficacy and Safety
The NDA submission is supported by an extensive clinical development program that evaluated more than 1,300 hereditary angioedema attacks across multiple studies. The pivotal Phase 3 RAPIDe-3 trial enrolled patients aged 12 years and older, including individuals with HAE with normal C1 inhibitor, and successfully met its primary endpoint and all 11 secondary efficacy endpoints with statistical significance. Clinical findings showed a median time to symptom relief of 1.28 hours, End of Progression™ within 17.48 minutes, and complete symptom resolution in a median of 11.95 hours. Throughout the study, deucrictibant IR demonstrated a well-tolerated safety profile, supporting its potential as an effective oral therapy for rapidly controlling acute HAE attacks.
Deucrictibant Designed to Transform Oral Treatment for Bradykinin-Mediated Angioedema
Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist designed to inhibit bradykinin signaling, the biological pathway responsible for the swelling episodes experienced by patients with hereditary angioedema. Pharvaris is developing two oral formulations of the therapy, including the immediate-release capsule for on-demand treatment of acute attacks and an extended-release tablet intended for long-term prophylactic prevention. The therapy has already received Orphan Drug Designation from the U.S. FDA, the European Commission, and Swissmedic, highlighting its importance in addressing unmet medical needs for patients with rare bradykinin-mediated diseases.
Advertisement
Pharvaris Advances Toward Potential Commercial Launch
According to Pharvaris, FDA acceptance of the NDA represents the culmination of nearly a decade of scientific research focused on developing convenient oral therapies for hereditary angioedema. The company has already initiated the expansion of its commercial infrastructure in anticipation of a potential product launch, subject to regulatory approval. Company leadership believes deucrictibant IR has the potential to establish a new standard of care by combining the proven therapeutic mechanism of bradykinin B2 receptor antagonism with the convenience of oral administration. If approved, the therapy could significantly improve treatment accessibility and patient experience while addressing an important unmet need in the management of acute hereditary angioedema attacks.
Source: Pharvaris press release
